Hip joint device

ABSTRACT

A medical device for fixation in a femoral bone of a patient is provided, the medical device comprises: a connecting portion adapted to be connected to a prosthetic hip joint contacting portion, an expanding portion, and a bone contacting surface on the expanding portion. The expanding portion could be adapted to be at least partially inserted into the femoral bone of a patient and to expand within the femoral bone, such that the bone contacting surface is placed in contact with the inside of the femoral bone for fixating the medical device to the femoral bone. By the fixation using an expanding portion a sturdy fixation is achieved without the need to go into or penetrate bone, or the need for fixation using bone cement.

This application is a continuation of U.S. Non-Provisional applicationSer. No. 13/382,708, filed 6 Jan. 2013, issued as U.S. Pat. No.9,486,318 on Nov. 8, 2016 which is the U.S. national phase ofInternational Application No. PCT/SE2010/050804, filed 12 Jul. 2010,which designated the U.S. and claims the benefit of U.S. ProvisionalNos.: 61/229,755, filed 30 Jul. 2009; 61/229,738 filed 30 Jul. 2009;61/229,739 filed 30 Jul. 2009; 61/229,743 filed 30 Jul. 2009; 61/229,745filed 30 Jul. 2009; 61/229,746 filed 30 Jul. 2009; 61/229,747 filed 30Jul. 2009; 61/229,748 filed 30 Jul. 2009; 61/229,751 filed 30 Jul. 2009;61/229,752 filed 30 Jul. 2009; 61/229,761 filed 30 Jul. 2009; 61/229,767filed 30 Jul. 2009; 61/229,778 filed 30 Jul. 2009; 61/229,786 filed 30Jul. 2009; 61/229,789 filed 30 Jul. 2009; 61/229,796 filed 30 Jul. 2009;61/229,735 filed 30 Jul. 2009; and which claims priority to SwedishApplication Nos.: 0900981-2 filed 10 Jul. 2009; 0900957-2 filed 10 Jul.2009; 0900958-0 filed 10 Jul. 2009; 0900959-8 filed 10 Jul. 2009;0900960-6 filed 10 Jul. 2009; 0900962-2 filed 10 Jul. 2009; 0900963-0filed 10 Jul. 2009; 0900965-5 filed 10 Jul. 2009; 0900966-3 filed 10Jul. 2009; 0900968-9 filed 10 Jul. 2009; 0900969-7 filed 10 Jul. 2009;0900970-5 filed 10 Jul. 2009; 0900972-1 filed 10 Jul. 2009; 0900973-9filed 10 Jul. 2009; 0900974-7 filed 10 Jul. 2009; 0900976-2 filed 10Jul. 2009 and 0900978-8 filed 10 Jul. 2009, the entire contents of eachof which are hereby incorporated by reference.

FIELD OF INVENTION

The present invention relates generally to a medical device forimplantation in a femoral bone.

BACKGROUND ART

The hip joint is a synovial joint, joining the pelvis to the proximalportion of the femoral bone. Synovial joints are the most common typesof joints in mammals, and are typical of nearly all limb joints. Thecontacting surfaces of said the pelvic, the acetabulum, and thecontacting surface of the femoral bone, the caput femur, are smooth androunded, and covered by articular cartilage. A synovial membrane,encapsulates the joint, forming a hip joint cavity, which containssynovial fluid. Outside the synovial membrane is a fibrous capsule andligaments, forming an articular capsule.

There are both natural and pathological processes leading todeteriorated joint function. With age and wear, the articular cartilagebecomes less effective as a shock absorber and a lubricated surface.Different degenerative joint diseases, such as arthritis,osteoarthritis, or osteoarthrosis, accelerate the deterioration.

Hip joint Osteoarthritis is a syndrome in which low-grade inflammationresults in pain in the hip joints, caused by abnormal wearing of theCartilage that acts as a cushion inside if the hip joint. This abnormalwearing of the cartilage also results in a decrease of the jointslubricating fluid called Synovial fluid. Hip joint Osteoarthritis isestimated to affect 80% of all people over 65 years of age, in more orless serious forms.

The present treatment for hip osteoarthritis comprises NSAID drugs,local injections of Hyaluronic acid or Glucocorticoid to helplubricating the hip joint, and replacing parts of the hip joint with aprosthesis through hip joint surgery.

The replacing of parts of the hip joint is one of the most commonsurgeries to date performed at hundreds of thousands of patients in theworld every year. The most common method comprises placing a metalprosthesis in Femur and a plastic bowl in Acetabulum. This operation isdone through an incision in the hip and upper thigh and through FasciaLata and the lateral muscles of the thigh. To get access to the joint,the supporting Capsule attached to Femur and Ilium needs to bepenetrated, making it difficult to get a fully functional joint afterthe surgery. Femur is then cut at the neck with a bone saw and theprosthesis is placed in femur either with bone cement or without.Acetabulum is slightly enlarged using an Acetabular reamer, and theplastic bowl is positioned using screws or bone cement.

The complications after hip joint surgery includes dislocation of thehip joint and loosening of the prosthesis from its fixation in thefemoral bone. The loosening and/or dislocation of the prosthesis couldbe induced by an abnormal strain being placed on the hip joint from e.g.the patient falling or making a rapid movement of the hip, or by abodily macrophage reaction.

SUMMARY

A medical device for fixation in a femoral bone of a patient isprovided, the medical device comprises: a connecting portion adapted tobe connected to a prosthetic hip joint contacting portion, an expandingportion, and a bone contacting surface on the expanding portion. Theexpanding portion could be adapted to be at least partially insertedinto the femoral bone of a patient and to expand within the femoralbone, such that the bone contacting surface is placed in contact withthe inside of the femoral bone for fixating the medical device to thefemoral bone. By the fixation using an expanding portion a sturdyfixation is achieved without the need to go into or penetrate bone, orthe need for fixation using bone cement.

According to one embodiment the medical device comprises a bent portionplaced between the connecting portion and an end portion of the medicaldevice, e.g. for adjusting to the anatomy of the femoral bone.

According to one embodiment, the connecting portion could comprise afixating portion adapted to fixate a prosthetic contacting portion. Thefixating portion could comprise a threaded portion, which could enablethe screw-fixation of a prosthetic hip joint contacting portion to theconnecting portion.

According to one embodiment, the medical device has a centrally placedlongitudinal axis reaching from the connecting portion to an endportion, and the expanding portion comprises a plurality of expansionmembers adapted to expand radially away from the longitudinal axis. Bythe plurality of expansion members the force from the expansion membersis evenly distributed throughout the surface of the inside of thefemoral bone.

The medical device could according to any of the embodiments herein havea centrally placed longitudinal axis reaching from the connectingportion to an end portion, and the medical device could comprise aplurality of expanding portions distributed axially along thelongitudinal axis of the medical device.

According to one embodiment the medical device could comprise aplurality of expanding portions distributed axially along thelongitudinal axis of the medical device and being adapted to radiallyexpand independently of each other to allow different expansion of thedifferent expanding portions.

According to another embodiment the medical device could compriseexpanding portions placed between the bent portion and the end portion,or between the bent portion and the connecting portion.

According to yet another embodiment the medical device comprises a firstand a second expanding portion, the first expanding portion is placedbetween the bent portion and the connecting portion, and the secondexpanding portion is placed between the bent portion and the endportion.

According to yet another embodiment the medical device comprises aplurality of expanding portions distributed axially along a longitudinalaxis of the medical device, the plurality of expanding portions areplaced between the bent portion and the end portion or between the bentportion and the connecting portion.

According to one embodiment, the expanding portion comprises adeformable expanding portion, wherein the expanding portion expands bythe deformable expanding portion deforming, such that the bonecontacting surface is placed in contact with the inside of the femoralbone for fixating the medical device to the femoral bone, wherein thedeformable expanding portion allows a larger contact with the bonecontacting surface.

According to one embodiment, the medical device further comprises anoperating device adapted to operate the expanding portion. The operationdevice could comprising a flexible member in communication with theconnecting portion and the end portion, the flexible member adapted tobe pulled in the direction of the connecting portion for exerting anaxial force on a part of the operating device causing, at leastpartially, radial expansion of the expanding portion. In otherembodiments, the operation device could comprise an elastic operationdevice adapted to exert an elastic force on the expanding portion. Theelastic operation device could for example be a spring.

According to one embodiment, the medical device further comprises anadjustment device for adjusting the tension of the elastic operationdevice and thus the force exerted by the expansion members. Theoperating device could further comprise a conical member adapted tocontact a corresponding surface of the expanding portion for expandingthe expanding portion. In one embodiment, the operating device couldcomprise a rotatable threaded portion adapted to engage a correspondingthreaded portion of the medical device for expanding the expandingportion. The operating device could according to one embodiment comprisea rotatable threaded portion adapted to engage a corresponding threadedportion of the conical member for operating the conical member andthereby the corresponding surface of the expanding portion for expandingthe expanding portion.

The bone contacting surface according to any of the embodiments hereincould comprise at least one tapered member adapted to at least partiallyenter the bone of the inside of the collum femur, or the bone contactingsurface could comprise a porous micro or nano structure adapted topromote the in-growth of bone in the medical device.

The medical device according to any of the embodiments, could furthercomprise a stabilizing member, which could be a stabilizing memberadapted to be placed in contact with a cut surface of the femoral boneand/or an outer surface of the femoral bone. The stabilizing membercould according to one embodiment be operable for exerting a force onthe femoral bone for further fixating the medical device to the femoralbone.

The femoral bone comprises a longitudinal axis extending along thefemoral bone, and the stabilizing member could according to oneembodiment be adapted to extend on the outside of the femoral bone alonga stabilizing portion of the longitudinal axis, and the expandingportion could be adapted to extend on the inside of the femoral bone,along at least a portion of the stabilizing portion of the longitudinalaxis, such that a portion of the femoral bone is clamped between theexpanding portion on the inside of the femoral bone and the stabilizingmember on the outside of the femoral bone.

According to one embodiment, the medical device further comprises aprosthetic hip joint contacting portion which could be adapted to bedetachably fixated to a fixating portion of the connecting portion. Thefixating portion of the prosthetic hip joint contacting portion couldcomprise a threaded portion corresponding to a threaded portion of thefixating portion of the connecting portion, such that the prosthetic hipjoint contacting portion can be screwed on to the connecting portion.

In any of the embodiments herein, the prosthetic contacting portioncould comprise a spherical convex contacting portion or a sphericalconcave contacting portion, and the prosthetic contacting portion couldcomprises the stabilizing described in relation to any of theembodiments herein.

According to yet another embodiment, the prosthetic contacting portioncould be rotatable in relation to the connecting portion, and theprosthetic contacting portion could be mechanically connected to anoperating device operating the expanding portion, such that theexpanding portion can be expanded by rotating the prosthetic contactingportion. The medical device could further comprise a locking memberadapted to lock the prosthetic contacting portion in relation to theconnecting portion.

According to one embodiment, the medical device further comprises alocking member adapted to lock the prosthetic contacting portion inrelation to the connecting portion.

According to one embodiment, the prosthetic contacting portion comprisesan artificial caput femur surface.

A method for mounting anyone of the embodiments herein for fixation ofthe medical device in a femoral bone of a patient is further provided.The method comprising: cutting the skin, dissecting a hip region of apatient, surgically affecting and open the femoral bone, inserting theexpanding portion of the medical device at least partially into thefemoral bone, and expanding within the femoral bone the expandingportion such that the bone contacting surface is placed in contact withthe inside of the femoral bone for fixating the medical device direct orindirect to the femoral cortical bone.

According to one embodiment, the medical device comprises a plurality ofexpanding portions distributed axially along a longitudinal axis of themedical device and the method further comprises the steps of; expandingsaid plurality of expanding portions towards the femoral cortical bone.

According to one embodiment, the medical device further comprises anoperating device adapted to operate the expanding portion, and themethod further comprises the steps of: operating manually or by a motorthe expanding portion to fixate the device towards the femoral corticalbone.

According to one embodiment, the expanding portions is suspended andadjustable to adjust the tension towards the femoral cortical bone, andthe method comprises the steps of; adjusting the expanding portion ofthe device.

Please note that any embodiment or part of embodiment as well as anymethod or part of method could be combined in any way. All examplesherein should be seen as part of the general description and thereforepossible to combine in any way in general terms.

BRIEF DESCRIPTION OF DRAWINGS

The invention is now described, by way of example, with reference to theaccompanying drawings, in which:

FIG. 1 shows the exposing of the caput femur through an incision in thethigh,

FIG. 2a shows the step of removing a proximal part of the caput femur,

FIG. 2b shows the cross section A-A of the collum femur,

FIG. 3a shows the medical device according to a one embodiment, in afirst state,

FIG. 3b shows the medical device according to a one embodiment, in asecond state,

FIG. 3c shows the medical device according to a one embodiment, in afirst state,

FIG. 3d shows the medical device according to a one embodiment, in asecond state,

FIG. 3e shows the medical device according to a one embodiment, in afirst state,

FIG. 3f shows the medical device according to a one embodiment, in asecond state,

FIG. 4a shows the medical device according to a one embodiment, in afirst state,

FIG. 4b shows the medical device according to a one embodiment, in asecond state,

FIG. 4c shows the medical device according to a one embodiment, in afirst state,

FIG. 4d shows the medical device according to a one embodiment, in asecond state,

FIG. 4e shows the medical device according to a one embodiment, in afirst state,

FIG. 4f shows the medical device according to a one embodiment, in asecond state,

FIG. 5a shows the medical device according to a one embodiment, whenplaced in a femoral bone,

FIG. 5b shows the medical device according to a one embodiment, whenplaced in a femoral bone,

FIG. 5c shows the medical device according to a one embodiment, whenplaced in a femoral bone,

FIG. 5d shows the medical device according to a one embodiment, whenplaced in a femoral bone,

FIG. 6a shows the medical device according to a one embodiment, whenplaced in a femoral bone,

FIG. 6b shows the medical device according to a one embodiment, whenplaced in a femoral bone,

FIG. 6c shows the medical device according to a one embodiment, whenplaced in a femoral bone,

FIG. 6d shows the medical device according to a one embodiment, whenplaced in a femoral bone,

FIG. 7a shows the medical device according to a one embodiment, in afirst state,

FIG. 7b shows the medical device according to a one embodiment, in asecond state,

FIG. 8a shows the medical device according to a one embodiment, in afirst state,

FIG. 8b shows the medical device according to a one embodiment, in asecond state,

FIG. 9a shows the medical device according to a one embodiment, in afirst state,

FIG. 9b shows the medical device according to a one embodiment, in asecond state,

FIG. 10 shows the medical device according to a one embodiment, whenplaced in a femoral bone,

FIG. 11a shows the medical device according to a one embodiment, whenplaced in a femoral bone,

FIG. 11b shows a portion of the medical device and the femoral bone, insection,

FIG. 12a shows the medical device according to a one embodiment, in afirst state,

FIG. 12b shows the medical device according to a one embodiment, in asecond state,

FIG. 13 shows the medical device according to a one embodiment, whenplaced in a femoral bone,

FIG. 14 shows the medical device according to a one embodiment, whenplaced in a femoral bone,

FIG. 15a shows the medical device according to a one embodiment, in afirst state,

FIG. 15b shows the medical device according to a one embodiment, in asecond state,

FIG. 16a shows the medical device according to a one embodiment, in afirst state,

FIG. 16b shows the medical device according to a one embodiment, in asecond state,

DETAILED DESCRIPTION

The hip joint is a synovial ball and socket joint which permits a largemotion range for allowing a plurality of different movements of thelower limb. From a neutral position the following movements of the hipjoint are normally possible: Lateral or external rotation, 30° with thehip extended, 50° with the hip flexed, medial or internal rotation 40°,extension or retroversion 20°, flexion or anteversion 140°, abduction50° with hip extended, 80° with hip flexed, adduction 30° with hipextended, 20° with hip flexed.

The anatomy of the hip joint and its surroundings is further disclosedin: Marieb et al., Human Anatomy, 2003, Benjamin Cummings, SanFrancisco, pages 195-202 and in Moore et al., Clinically orientedanatomy, 1999, Lippincott, Williams & Wilkins, Baltimore, pages 501-653,both hereby incorporated by reference.

A severe but yet common complication following hip joint surgery is theloosening of the prosthesis from its fixation in the femoral bone. Theloosening could be induced by an abnormal strain being placed on the hipjoint from e.g. the patient falling or making a rapid movement of thehip. Most hip joint prosthesis are made from a material harder than thebone to which the prosthesis is fixated, which adds to the tensioncreated between the fixations and the bone of the patient. Bone cementcould further be used to fixate prosthesis, which could create a bodilymacrophage reaction excavating the bone cement and thus causingloosening of the prosthesis. Other fixations, such as fixations usingorthopedic screws penetrating the bone could also create a bodilyreaction rejecting the foreign matter of the medical device. Eliminatingthe use of bone cement and orthopedic screws, and at the same timecreating a stabile fixation would be very advantageous, furthermore,creating a fixation that has the ability to move slightly in thefixation in response to exposure to force e.g. from the patient fallingwould be even more advantageous.

In the following a detailed description of preferred embodiments of thepresent invention will be given. In the drawing figures, like referencenumerals designate identical or corresponding elements throughout theseveral figures. It will be appreciated that these figures are forillustration only and are not in any way restricting the scope of theinvention. Thus, any references to direction, such as “up” or “down”,are only referring to the directions shown in the figures. Also, anydimensions etc. shown in the figures are for illustration purposes.

The functional position of an implantable medical device or prosthesisis the position in which the hip joint can perform functional hipmovements.

Elastic deformation is when a material deforms under stress (e.g.external forces), but returns to its original shape when the stress isremoved. A more elastic material is to be understood as a materialhaving a lower modulus of elasticity. The elastic modulus of an objectis defined as the slope of its stress-strain curve in the elasticdeformation region. The elastic modulus is calculated as stress/strain,where stress is the force causing the deformation, divided by the areato which the force is applied; and strain is the ratio of the changecaused by the stress.

Elasticity is to be understood as a materials ability to deform in anelastic way.

Stiffness is to be understood as the resistance of an elastic body todeformation by an applied force.

FIG. 1 shows a lateral view of a human patient when a conventional hipjoint procedure is being performed. An incision in the thigh region ofthe patient has been made and the femoral bone 7 comprising the collumfemur 6 and the caput femur 5 has been dislocated from its usualposition in the hip joint. In the usual position the caput femur 5 is inconnection with the acetabulum, which is a part of the pelvic bone 9.The caput femur 5 is fixated to the pelvic bone by means of itsarticular capsule 650 (capsular ligament), which is a strong and densecapsule that surrounds the collum femur 6, and is attached, to thefemoral bone 7, at the intertrochanteric line (the line between thetrochanter major 651 and the trochanter minor 652), and to the pelvicbone 9 in the area surrounding the acetabulum. For clarification offurther parts of the disclosure, both the caput and collum femur areportions of the femoral bone.

FIG. 2a shows the proximal part of the caput femur 5 being removed e.g.by means of a bone saw. A surface of a section 601 is thus createdperpendicularly to a length axis of the collum 6 and caput 5 femur.

FIG. 2b shows a section A-A of the collum femur 6, as shown in FIG. 2a .The section A-A shows the collum femur 6 (as the rest of the femoralbone) comprising cortical bone 601, the outer more sclerotic bone, andcancellous bone 610, the inner porous bone located in the bone marrow.

FIG. 3a shows a medical device for fixation in the femoral bone of apatient. The medical device comprises a connecting portion 653 connectedto a prosthetic contacting portion 45, in the embodiment shown being aconvex prosthetic contacting portion 45. The medical device furthercomprising an expanding portion 654, and a bone contacting surface 655on the expanding portion 654. The expanding portion 654 is adapted to beat least partially inserted into the femoral bone of a patient and toexpand within the femoral bone such that the bone contacting surface 655is placed in contact with the inside of the femoral bone for fixatingthe medical device to the femoral bone. The medical device has acentrally placed longitudinal axis 656 reaching from the connectingportion 653 to an end portion 657, and wherein the expanding portion 654comprises a plurality of expansion members 658 a-d, adapted to expandradially away from the longitudinal axis 656.

The medical device further comprises an operating device 659 adapted tooperate the expanding portion 564, according to the embodiment shown inFIG. 3a, 3b the operating device 659 comprises a conical member 659adapted to contact a corresponding surface 660 of the expanding portion654 for expanding the expanding portion 654. The operating device 659further comprises a rotatable threaded portion 661 adapted to engage acorresponding threaded portion of the conical member 659 for moving theconical member 659 along the centrally placed longitudinal axis 656 inthe direction of the connecting portion 653. The threaded portion 661 isa portion of an elongated member 662, which according to the embodimentshown in FIG. 3a, 3b reaches from the end portion 657 to the top part ofthe prosthetic contacting portion 45 having a tool engaging portion 663,such that the elongated member 662 can be rotated using a tool forrotating the threaded portion and thereby the moving the conical member659.

The bone contacting surfaces 655, according to the embodiments shown inFIG. 3a, 3b comprise needle or nail like tapered members 664 adapted toat least partially enter the bone of the inside of the collum femur forfurther fixating the medical device in the femoral bone, especiallyaxially along the centrally placed longitudinal axis 656. In otherembodiments, not shown, the bone contacting surface comprises a porousmicro- or nano-structure adapted to promote the in-growth of bone in themedical device. The bone contacting surface 655 is here described inrelation to the embodiment of FIGS. 3a and 3b , however the adaptationof the bone contacting surface 655 is equally applicable in all of theembodiments disclosed herein.

FIG. 3b shows the medical device according to the embodiment shown inFIG. 3b when the elongated member 662 has been rotated by means of atool such that the threaded portion 661 has moved the conical member 659affecting the corresponding surface of the expansion members 658 a-d andthus expanding the expanding portion 654 such that the bone contactingsurface 655 is adapted to be placed in contact with the inside of thefemoral bone.

FIG. 3c shows the medical device according to an embodiment comprisingmost elements described with reference to FIGS. 3a and 3b , thedifference being that the prosthetic hip joint contacting portion 45 isdetachably fixated to a fixating portion 665 of the connecting portion653. The fixating portion 665 is adapted to engage a fixating portion667 of the prosthetic hip joint contacting portion 45 for fixating theprosthetic hip joint contacting portion 45 to the connecting portion653. According to the embodiment shown in FIGS. 3c and 3d the fixatingportion 665 and the fixating portion 667 of the prosthetic hip jointcontacting portion 45 comprises corresponding threaded portions 666,such that the prosthetic hip joint contacting portion 45 can be screwedon to the connecting portion 653. The elongated member 662, according tothe embodiment shown in FIG. 3c, 3d ends at the top of the connectingportion 653, where the tool engaging portion 663 is placed.

FIG. 3d shows the medical device according to the embodiment shown inFIG. 3c when the elongated member 662 has been rotated by means of atool such that the threaded portion 661 has moved the conical member 659affecting the corresponding surface 660 of the expansion members 658 a-dand thus expanding the expanding portion 654 such that the bonecontacting surface 655 is adapted to be placed in contact with theinside of the femoral bone.

FIG. 3e shows the medical device according to an embodiment comprisingmost elements described with reference to FIGS. 3c and 3d , thedifference being that the medical device further comprises a stabilizingmember 668 adapted to be placed in contact with a cut surface (610 inFIGS. 2a and 2b ) of the femoral bone along the centrally placedlongitudinal axis 656 and with the outer surface of the femoral bone,substantially perpendicular to the centrally placed longitudinal axis656. In the embodiment shown in FIGS. 3e, 3f , the stabilizing member668 is adapted to be in contact with both the cut surface of the femoralbone and the outer surface of the femoral bone, however, it is equallyconceivable that the stabilizing member 668 is used in connection withany of the embodiments herein and adapted to only contact the cutsurface of the femoral bone or only contact the outer surface of thefemoral bone. The stabilizing member 668 further stabilizes the medicaldevice axially by the contact with the cut surface, and radially by thecontact with the outer surface of the femoral bone. The stabilizingmember could be adapted to completely encircle the outside of thefemoral bone 7 or covering the entire cut surface 610, or thestabilizing member could comprise multiple parts each covering a smallerportion of the cut surface or the outer surface of the femoral bone 7.In the embodiment shown in FIGS. 3e and 3f the medical device is shownin connection with the prosthetic hip joint contacting portion 45disclosed with reference to FIGS. 3c and 3d , however, it is equallyconceivable that the medical device shown in FIGS. 3e and 3f is used inconnection with the prosthetic hip joint contacting portions 45disclosed with reference to FIG. 3a, 3b or 10, 11.

FIG. 3f shows the medical device according to the embodiment shown inFIG. 3e when the elongated member 662 has been rotated by means of atool such that the threaded portion 661 has moved the conical member 659affecting the corresponding surface 660 of the expansion members 658 a-dand thus expanding the expanding portion 654 such that the bonecontacting surface 655 is adapted to be placed in contact with theinside of the femoral bone.

FIG. 4a shows a medical device according to an embodiment in which theexpanding portion 654 is identical to the expanding portion of themedical devices disclosed with reference to FIGS. 3a-3f . The medicaldevice according to the embodiment shown in FIGS. 4a and 4b furthercomprises a bent portion 670 placed between the connecting portion 653and the end portion 657 of the medical device for placing the expandingportion 654 further down in the femoral bone. The elongated member 662operating the conical member 659 according to this embodiment comprisesa universal joint 671 enabling the bent portion 670 in the elongatedmember 662 while still maintaining the rotating function of theelongated member 662. In the embodiment disclosed with reference toFIGS. 4a and 4b the elongated member 662 is operated by the elongatedmember 662 being connected to the prosthetic hip joint contactingportion 45, such that the elongated member 662 is rotated by rotating ofthe prosthetic hip joint contacting portion 45. The medical devicefurther comprises a locking member 672 adapted to lock the prostheticcontacting portion 45 in relation to the connecting portion 653, suchthat the prosthesis can be used in a functional hip joint without theprosthetic contacting portion 45 rotating in relation to the connectingportion 653.

In another embodiment (not shown), the medical device comprises twoexpanding portions, one placed between the end portion 657 and the bentportion 670, and the other one placed between the connecting portion 45and the bent portion 670.

FIG. 4b shows the medical device according to the embodiment shown inFIG. 4a when the elongated member 662 has been rotated by the prostheticcontacting portion 45 being rotated such that the expanding portion 654has been expanded.

FIG. 4c shows an embodiment of the medical device similar to theembodiments shown in FIGS. 4a and 4b with the difference that themedical device in the embodiment in FIGS. 4c and 4d has the prostheticcontacting portion described with reference to FIGS. 3c -3 f.

FIG. 4d shows the medical device according to the embodiment shown inFIG. 4c when the elongated member 662 has been rotated by means of atool such that the threaded portion 661 has moved the conical member 659affecting the corresponding surface 660 of the expansion members 658 a-dand thus expanding the expanding portion 654 such that the bonecontacting surface 655 is adapted to be placed in contact with theinside of the femoral bone.

FIGS. 4e and 4f shows an embodiment of the medical device similar to theembodiments shown in FIGS. 4c and 4d , the difference being that themedical device further comprises a stabilizing member 668 adapted to beplaced in contact with a cut surface (610 in FIGS. 2a and 2b ) of thefemoral bone along the centrally placed longitudinal axis 656 and withthe outer surface of the femoral bone, substantially perpendicular tothe centrally placed longitudinal axis 656. In the embodiment shown inFIGS. 3e, 3f , the stabilizing member 668 is adapted to be in contactwith both the cut surface of the femoral bone and the outer surface ofthe femoral bone, however, it is equally conceivable that thestabilizing member 668 is used in connection with any of the embodimentsherein and adapted to only contact the cut surface of the femoral boneor only contact the outer surface of the femoral bone. The stabilizingmember 668 further stabilizes the medical device axially by the contactwith the cut surface, and radially by the contact with the outer surfaceof the femoral bone. In the embodiment shown in FIGS. 4e and 4f themedical device is shown in connection with the prosthetic hip jointcontacting portion 45 disclosed for example with reference to FIGS. 3cand 3d , however, it is equally conceivable that the medical deviceshown in FIGS. 4e and 4f is used in connection with the prosthetic hipjoint contacting portions 45 disclosed for example with reference toFIG. 3a, 3b or 10, 11.

FIG. 5a shows the medical device described with reference to FIGS. 3cand 3d when placed in the femoral bone 7, particularly in the collumfemur 6 portion of the femoral bone 7. The expanding portion has beenexpanded such that the bone contacting surface (here comprising taperedmembers) is placed in contact with the inside of the femoral bone.

FIG. 5b shows the medical device described with reference to FIGS. 3eand 3f when placed in the femoral bone 7, particularly in the collumfemur 6 portion of the femoral bone 7. The expanding portion has beenexpanded such that the bone contacting surface (here comprising taperedmembers) is placed in contact with the inside of the femoral bone.According to this embodiment the medical device further comprises astabilizing member 668 further stabilizing the medical device axially bythe contact with the cut surface 610, and radially by the contact withthe outer surface of the femoral bone.

FIG. 5c shows the medical device when placed and expanded in the femoralbone. The medical device shown in FIG. 5c comprises a stabilizing member668 fixated to the prosthetic hip joint contacting portion 45 such thatthe stabilizing member is attached to the cut surface 610 and/or theouter surface of the femoral bone when the prosthetic hip jointcontacting portion 45 is fixated to the fixating portion 665 (furtherdisclosed with reference to FIG. 3c ). The stabilizing member could beadapted to completely encircle the outside of the femoral bone 7 orcovering the entire cut surface 610, or the stabilizing member couldcomprise multiple parts each covering a smaller portion of the cutsurface or the outer surface of the femoral bone 7.

FIG. 5d shows the medical device shown in FIG. 5c when fixated to thefixating portion of the medical device, such that the medical devicewith the prosthetic hip joint contacting surface is in its functionalstate fixated to the femoral bone 7.

FIG. 6a shows the medical device described with reference to FIGS. 4cand 4d when placed inside of the femoral bone 7. The expanding portionhas been expanded such that the bone contacting surface 655 is placed incontact with the inside of the femoral bone. The bent portion 670 isanatomically adapted to fit in the natural bend of the femoral bone inthe area of the intertrochanteric line.

FIG. 6b shows the medical device described with reference to FIGS. 4eand 4f when placed inside of the femoral bone 7. The expanding portionhas been expanded such that the bone contacting surface 655 is placed incontact with the inside of the femoral bone, and the stabilizing portionis placed in contact with the cut surface of the femoral bone 7 andoutside of the femoral bone 7. The bent portion 670 is anatomicallyadapted to fit in the natural bend of the femoral bone in the area ofthe intertrochanteric line.

FIG. 6c shows the medical device described with reference to FIGS. 4cand 4d , with a stabilizing member 668 fixated to the prosthetic hipjoint contacting portion 45, as in the embodiment shown with referenceto FIG. 5c , such that the stabilizing member is attached to the cutsurface 610 and/or the outer surface of the femoral bone when theprosthetic hip joint contacting portion 45 is fixated to the fixatingportion 665 (further disclosed with reference to FIG. 3c ). Thestabilizing member could be adapted to completely encircle the outsideof the femoral bone 7 or covering the entire cut surface 610, or thestabilizing member could comprise multiple parts each covering a smallerportion of the cut surface or the outer surface of the femoral bone 7.The medical device is here shown when placed inside of the femoral bone7. The expanding portion has been expanded such that the bone contactingsurface 655 is placed in contact with the inside of the femoral bone.The bent portion 670 is anatomically adapted to fit in the natural bendof the femoral bone 7 in the area of the intertrochanteric line.

FIG. 6d shows the medical device shown in FIG. 6c when fixated to thefixating portion of the medical device, such that the medical devicewith the prosthetic hip joint contacting surface is in its functionalstate fixated to the femoral bone 7.

FIGS. 7a and 7b shows the medical device in an embodiment similar to theembodiment disclosed with reference to FIGS. 3c and 3d , however in theembodiment of FIGS. 7a and 7b the operation device of the medical devicefurther comprises an elastic operation device 680 adapted to press onthe conical member 659 for expanding the expanding portion 654. Theelastic member could be adapted to be released after the insertion ofthe medical device into the femoral bone 5 thereby creating an elasticpressure on the expansion members 658 a, 658 b for elastically pressingthe bone contacting surfaces 655 onto the inside of the femoral bone.The elastic operation device 680 is according to the embodiment shown inFIGS. 7a and 7b released by turning the elongated member 662 with a toolengaging the tool engaging portion 663. The elastic portion enables afixation of the medical device to the femoral bone that has the abilityto move slightly in the fixation in response to exposure to force e.g.from the patient falling. In the embodiment shown in FIGS. 7a and 7b theelastic operation device is a spring which could be a linear spring or anon-linear spring allowing a first movement with a first elasticity andfurther movement with a second elasticity that requires greater force.The elastic operation device could according to other embodimentscomprise an elastic material, such as an elastomer.

FIG. 7b shows the medical device when the elastic operation device 680has been released such that the expanding portion has been expandedpressing the bone contacting surfaces against the inside of the femoralbone 7.

FIGS. 8a and 8b shows an embodiment of the medical device comprising theelements described with references to FIGS. 7a and 7b , with theaddition of an adjustment device 681 for adjusting the tension of theelastic operation device 680 and thus the force exerted by the expansionmembers 658 a-d. The adjustment device 681 is adjusted by means of theelongated member 662 comprising a threaded portion 682 which interactswith a corresponding threaded portion of the adjustment device 681.

FIG. 8b shows the medical device when the elastic operation device 680has been released such that the expanding portion has been expandedpressing the bone contacting surfaces against the inside of the femoralbone 7, the adjustment device can now be used to adjust the tension ofthe elastic operation device 680.

FIGS. 9a and 9b shows the medical device according to an embodiment inwhich the expanding portion 654 comprises a deformable expanding portion654, wherein the expanding portion expands by the deformable expandingportion 654 deforming, such that the bone contacting surface 655 isplaced in contact with the inside of the femoral bone for fixating themedical device to the femoral bone. The deformable expanding portion 654deforms at deformation points 684 by the threaded member 661 pulling theend portion 657 towards the connecting portion 653 thus expanding theexpanding portion 654 pushing the bone contacting surfaces 655 radiallysuch that they are placed in contact with the inside of the bone of thefemoral bone.

FIG. 9b shows the medical device when the deformable expanding portion654 has expanded pressing the bone contacting surfaces 655 against theinside of the femoral bone 7.

FIG. 10 shows the medical device according to an embodiment in which theprosthetic contacting portion comprises a spherical concave contactingportion 110 in which a spherical convex contacting portion fixated tothe pelvic bone is adapted to be placed. The prosthetic sphericalconcave contacting portion 110 has a centrally placed longitudinal axis656 along which the prosthetic spherical concave contacting portion 110is placed. The prosthetic spherical concave contacting portion 110 has alargest radius 689 perpendicular to the centrally placed longitudinalaxis 656 and a clasping portion 685 having a radius 688 perpendicular tothe centrally placed longitudinal axis 656 being shorter than thelargest radius 689, such that the prosthetic spherical concavecontacting portion 110 can clasp a spherical convex contacting portionfor fixation of the spherical convex contacting portion in the sphericalconcave contacting portion. The stabilizing member 668 is according tothis embodiment integrated in the spherical concave contacting portion110 and is placed in connection with the cut surface of the femoralbone, here at the area of the caput femur, and the outer surface of thefemoral bone 7. The stabilizing member 668 has a largest inner radius686 to the centrally placed longitudinal axis 656 and a clasping portion690 having a shorter radius 687 to the centrally placed longitudinalaxis 656, such that the stabilizing member clasps a portion of the caputfemur for mechanically fixating the spherical concave contacting portion110 to the femoral bone 7.

FIG. 11a shows the medical device according to an embodiment in whichthe spherical concave contacting portion 110 is identical to thespherical concave contacting portion 110 described with reference toFIG. 10. The difference in the embodiment described with reference toFIG. 11a is that the medical device comprises a bend 670 and that theexpanding portion is placed between the bend 670 and the end portion657. In other embodiments, the clasping portions 690 could be operableor adjustable for further fixating the medical device to the corticalbone, such as disclosed with reference to FIGS. 12a, 12b . The claspingportions 690 could be operable for example by means of a screw fortightening the clasping portions 690 to the cortical bone, which couldsqueeze the cortical bone between the clasping portions 690 and the partof the medical device placed inside of the femoral bone.

FIG. 11b shows an embodiment similar to toe embodiment disclosed withreference to FIG. 11a with the difference that an orthopedic screw 121 bis placed between the stabilizing member 668 and the spherical concavecontacting portion 110, penetrating the cortical bone of the femoralbone. The orthopedic screw 121 b could in other embodiments be used incombination with the clasping portion 690 disclosed with reference toFIG. 11a for further fixating the medical device to the femoral bone.

The spherical concave contacting portion as shown in FIGS. 10 and 11 isshown as fixedly fixated to the connecting portion, however, it isequally conceivable that the spherical concave contacting portion isfixated to the connecting section in accordance with the principlesdescribed with reference to FIGS. 3c and 3d or 4 a and 4 b.

FIGS. 12a and 12b shows the medical device according to an embodiment inwhich the medical device comprises an operable stabilizing member 668,operable for exerting a force on the femoral bone for further fixatingthe medical device to the femoral bone. The operable stabilizing member668 comprises a clamping portion 693 operable by means of an operationscrew 692 for clamping a portion of the femoral bone between theclamping portion 693 and the connecting portion 654 of the medicaldevice. The difference between the embodiments of FIGS. 12a and 12b isthat the embodiment of FIG. 12 a comprises a bent portion 670 such thatthe expanding portion 654 is placed between the bent portion 670 and theend portion 657.

FIG. 13 shows the medical device according to the embodiment shown inFIG. 12a when positioned inside of the femoral bone 7. The operablestabilizing member 668 has been operated for clamping a portion of thefemoral bone 7 for further fixating the medical device to the femoralbone.

FIG. 14 shows the medical device according to an embodiment in which themedical device comprises a longitudinal axis 656 extending along thefemoral bone 7. The stabilizing member extends on the outside of thefemoral bone 7 along a stabilizing/clamping portion, and wherein theexpanding portion 654 is extending on the inside of the femoral bone 7,along at least a portion of the stabilizing portion 693 of thelongitudinal axis 656, such that a portion of the femoral bone 7 isclamped between the expanding portion 654 on the inside of the femoralbone 7 and the stabilizing member 686 on the outside of the femoral bone7.

FIG. 15a shows the medical device according to an embodiment in whichthe medical device has a centrally placed longitudinal axis 656 reachingfrom the connecting portion 653 to an end portion 657, wherein themedical device comprises a plurality of expanding portions 654 a-d,distributed axially along the longitudinal axis 656 of the medicaldevice. The plurality of expanding portions 654 a-d distributed axiallyalong the longitudinal axis 656 of the medical device is adapted toradially expand independently of each other, to allow differentexpansion of the different expanding portions 654 a-d. The differentexpansion could allow the expanding portions 654 a-d to adapt to theuneven surfaces of the anatomy of the inside of the femoral bone. Sincethe different expanding portions expand independently of each other, oneexpanding portion 654 a will expand until the bone contacting surface655 of that particular expanding portion is placed in contact with thebone of the inside of the femoral bone, after which the other expandingportions 654 b-d will continue to expand until their respective bonecontacting surface is placed in contact with the inside of the femoralbone. Each expanding portion comprises four expansion members 658 a-deach having a sloped surface 660 corresponding to a sloped surface 696of the conical members 659, such that the conical members presses theexpansion members radially from the longitudinal axis 656 when theconical members 659 are moved in the direction of the connecting portion653.

FIG. 15b shows the medical device when the expanding portions 654 a-dhas been expanded for pressing the bone contacting surfaces 655 againstthe inside of the femoral bone 7.

FIG. 16a shows an embodiment of the medical device similar to theembodiment disclosed with reference to FIGS. 15a and 15b , thedifference being that the embodiment of FIGS. 16a and 16b comprises abent portion 670 and that a plurality of expanding portions are placedboth between the bent portion 670 and the connecting portion 653, andbetween the end portion 657 and the bent portion 670 such that themedical device can be fixated by expanding portions 654 expanding bothin the collum area of the femoral bone and in an area below theintertrochanteric line. However, it is equally conceivable in otherembodiments that the plurality of expanding portions 654 are place onlybetween the bent portion 670 and the connecting portion 653 or onlybetween the end portion and the bent portion 670. The threaded portionis fixated to a flexible member 697 such that the flexible member 697 isin communication with the connecting portion 653 and the end portion657, the flexible member 697 being adapted to be pulled in the directionof the connecting portion 653 for exerting an axial force on a expandingportions 654 a-d causing radial expansion of the expanding portions. Theflexible member 697 could for example be a wire.

16 b shows the medical device when the expanding portions 654 a-d hasbeen expanded for pressing the bone contacting surfaces 655 against theinside of the femoral bone 7.

The embodiments disclosed with reference to FIGS. 15 and 16 could beused in combination with any prosthetic hip joint contacting portion,such as the contacting portions disclosed with reference to FIGS. 3a,3c, 4a and 10.

The stabilizing member disclosed throughout the description and/or themedical device comprising the expanding portion disclosed throughout thedescription, could be further fixated using an adhesive, such as bonecement, or a mechanical fixation element, such as orthopedic screws.

The medical device according to any of the embodiments could comprise atleast one material selected from a group consisting of:polytetrafluoroethylene (PTFE), perfluoroalkoxy (PFA) and fluorinatedethylene propylene (FEP). It is furthermore conceivable that contactingportions, the elastic operation device, or the entire medical devicecomprises a metal alloy, such as cobalt-chromium-molybdenum or titaniumor stainless steel. Further conceivable materials are polyethylene, suchas cross-linked polyethylene or gas sterilized polyethylene. The use ofceramic material is also conceivable, in the contacting surfaces or theentire medical device such as zirconium or zirconium dioxide ceramics oralumina ceramics. The part of the medical device in contact with humanbone for fixation of the medical device to human bone, such as the bonecontacting surface, could comprise a poorhouse structure which could bea porous micro or nano-structure adapted to promote the growth-in ofhuman bone in the medical device for fixating the medical device. Theporous structure could be achieved by applying a hydroxy-apatite (HA)coating, or a rough open-pored titanium coating, which could be producedby air plasma spraying, a combination comprising a rough open-poredtitanium coating and a HA top layer is also conceivable. The contactingportions could be made of a self lubricated material such as a waxypolymer, such as PTFE, PFA, FEP, PE and UHMWPE, or a powder metallurgymaterial which could be infused with a lubricant, which preferably is abiocompatible lubricant such as a Hyaluronic acid derivate. It is alsoconceivable that the material of contacting portions or surfaces of themedical device herein is adapted to be constantly or intermittentlylubricated. According to some embodiments the parts or portions of themedical device could comprise a combination of metal materials and/orcarbon fibers and/or boron, a combination of metal and plasticmaterials, a combination of metal and carbon based material, acombination of carbon and plastic based material, a combination offlexible and stiff materials, a combination of elastic and less elasticmaterials, Corian™ or acrylic polymers.

Please note that any embodiment or part of embodiment as well as anymethod or part of method could be combined in any way. All examplesherein should be seen as part of the general description and thereforepossible to combine in any way in general terms.

The invention claimed is:
 1. A medical device for fixation in a femoralbone of a patient, the medical device comprising: a. a connectingportion adapted to be connected to or integrated in a prostheticcontacting portion; and b. a plurality of expanding portions having abone contacting surface, wherein the expanding portions are adapted tobe at least partially inserted into the femoral bone of a patient and toexpand within the femoral bone such that the bone contacting surface isplaced in contact with an inside of the femoral bone for fixating themedical device, directly or indirectly, to the femoral cortical bone;wherein the plurality of expanding portions are distributed along alongitudinal extension of the medical device, and each expanding portioncomprises a sloped surface corresponding to a sloped surface of acooperating conical member, such that each cooperating conical memberpresses each expanding portion radially from a longitudinal axis whenthe cooperating conical member is moved in the direction of theconnecting portion so that the bone contacting surface of the expandingportions are radially distanced from the cooperating conical members,and wherein each expanding portion is separable from each conical memberso as to allow an individual expansion of said plurality of expandingportions.
 2. The medical device according to claim 1, wherein: theconnecting portion is adapted to be at least partially inserted into thefemoral bone; and a clamping portion is adapted to clamp the femoralbone between the clamping portion and the connecting portion.
 3. Themedical device according to claim 2, wherein: the medical device has acentrally placed longitudinal axis reaching from the connecting portionto an end portion; the plurality of expanding portions and the clampingportion are adapted to be adjusted in a radial direction relative to thecentrally placed longitudinal axis.
 4. The medical device according toclaim 1, further comprising a stabilizing member having a clampingportion adapted to be placed in contact with an outer surface of thefemoral bone and operable for adjustably exerting a force on the outersurface for fixating the medical device to the femoral bone, wherein thestabilizing member is adapted to be placed in contact with a cut surfaceof the femoral bone.
 5. The medical device according to claim 1, whereinthe connecting portion comprises a fixating portion adapted to fixate aprosthetic contacting portion.
 6. The medical device according to claim5, wherein the fixating portion comprises a threaded portion.
 7. Themedical device according to claim 1, wherein the medical devicecomprises a bent portion placed between the connecting portion and anend portion of the medical device.
 8. The medical device according toclaim 1, wherein the medical device comprises a bent portion placedbetween the connecting portion and an end portion of the medical device,and wherein the plurality of expanding portions are placed between atleast one of: the bent portion and the end portion, and the bent portionand the connecting portion.
 9. The medical device according to claim 1,wherein the bone contacting surfaces of each of the plurality ofexpanding portions comprises at least one tapered member adapted to atleast partially enter a bone at an inside of a collum femur.
 10. Themedical device according to claim 1, wherein the bone contactingsurfaces of each of the plurality of expanding portions comprises aporous micro or nano structure adapted to promote an in-growth of bonein the medical device.
 11. The medical device according to claim 1,wherein the medical device further comprises a prosthetic hip jointcontacting portion, wherein the prosthetic hip joint contacting portioncomprises at least one of: an adaptation to be detachably fixated to afixating portion of the connecting portion; a prosthetic hip jointcontacting fixating portion adapted to engage the fixating portion ofthe connecting portion for fixating the prosthetic hip joint contactingportion to the connecting portion; a threaded portion corresponding to athreaded portion of the fixating portion of the connecting portion, suchthat the prosthetic hip joint contacting portion can be screwed on tothe connecting portion; a spherical convex contacting portion; aspherical concave contacting portion; and an artificial caput femursurface.
 12. The medical device according to claim 1, wherein eachexpanding portion comprises four expansion members.